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  • How Much Do You Really Know About Your CDMO’s Equipment (And How Much Should You)?
    How Much Do You Really Know About Your CDMO’s Equipment (And How Much Should You)?

    The first article in this series discussed the physical elements of facility design that sponsors look for in contract development and manufacturing organizations’ (CDMOs) manufacturing facilities. This second installment describes sponsors’ requirements for dedicating equipment to GMP operations, equipment redundancy, and transparency of equipment and facility issues. 

  • Supplier Selection In The Time Of Brexit: How To Get It Right
    Supplier Selection In The Time Of Brexit: How To Get It Right

    The ongoing Brexit negotiations between the British Parliament and the EU has left pharma supply chain managers scrambling for cover. As recently as October 2018, the probability of a no-deal scenario was low and it made little sense to invest in or commit to alternate plans, but this changed when Parliament rejected Prime Minister Theresa May's deal in December. The politics are not as important to business as the conclusion: The best way to mitigate disruption is to more heavily weigh finding alternate ex-U.K. suppliers versus waiting it out. Negotiating deals and supply agreements takes time, as does the logistics of tech transfer and moving materials. So risk management, timing, and terms are key success factors.

  • For Whom Is Bioprocessing Capacity Scarce?
    For Whom Is Bioprocessing Capacity Scarce?

    ISR data, collected for the purpose of improving our understanding of the much-anticipated bioprocessing capacity crunch, reveals that it is not a matter of if or when a capacity crunch will impact the biopharmaceutical industry; instead, it’s a question of who, or which types of drug innovators, will be impacted.

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PHARMA OUTSOURCING WHITE PAPERS

Cell Therapy Logisitics Cell Therapy Logisitics

Having a sound logistics strategy is critical to ensuring this living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.This paper will walk through key considerations for developing a successful logistics strategy for the management of cell-based material.

Avoiding Hemolysis Blood Sample Collection Processing Avoiding Hemolysis Blood Sample Collection Processing

Hemolysis is a primary driver of the need for re-draw, resulting in wasted time and resources. This paper explains how can hemolysis be prevented during specimen collection as well as hemolysis and specimen handling.

Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production

Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.

Standarizing Biosample Management - Why Use Collection Kits?

Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.

Top 10 Questions To Ask Your Clinical Supply Vendor About Temperature Sensitive Drugs

Over the years, an entire system called ‘cold chain supply (or cold chain transport)’ has developed in the food industry to ensure that foods that need to be kept cold are stored and transported in appropriate conditions and are monitored so consumers and regulators can be assured of their safety.

The Race To Phase III: A Cautionary Tale Of Scalability

Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Zydis® ODT - Improved Therapeutic Profile

Zydis® fast dissolve formulation for Zelapar® (Selegiline anti-Parkinson’s compound) had a positive impact on the patient compliance as compared to the Selegiline traditional tablets.

Medium Preparation For Single-Use Fermentation

To overcome many of the challenges associated with stainless steel vessels, single‑use fermentors offer an increasingly viable alternative. 

Advancing Vaccine Development
With extensive experience in vaccines development, as well as market access and commercialization strategy, Quintiles is uniquely qualified to be your ally in vaccines.
Thermoinducible Expression Of DNA Polymerase I

Thermo Scientific HyPerforma Single-Use Fermentor is a unique, robust, and purpose-built solution for microbial fermentation applications, offering flexibility, and efficiency found in single-use systems. 

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OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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